510(k) · Cleared
ClearedCS 7600
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Carestream Health, Inc. · MUH System, X-Ray, Extraoral Source, Digital
Cleared on Sep 23, 2011 as substantially equivalent to K060079 (Eastman Kodak Company, 2006) and 1 other predicate after a 102-day review. Its family tree reaches back 2 generations to 1994.
- Decided
- Sep 23, 2011
- Review
- 102 days
- Class
- Class II
- Product code
- MUH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K934949 (1994). 3 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K934949 | Digora | Orion Corporation Soredex | 1994 | — |
| −1 | K041050 | Digora Optime (or Digora Ontime) | Soredex Palodex Group OY | 2004 | 4 |
| 0 (this device) | K111649 | CS 7600 | Carestream Health, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MUH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MUH device
- #1 K242778 X Sensor (Model: IOS-A15IF, HDI-15DGF)score 16.0 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K060079 | Kodak Model CR-7400 Digital Radiography SystemSummary page 2…ses RFJD technology to automatically recognize imaging plates as they are scanned. 7. Substantial Equivalence The CS 7600 is substantially equivalent the Kodak CR 7400 (K060079) and the Soredex Digora Optime (K041050). Each listed device is a computed radiography device utilizing phosphor plates for denta… | 2006 |
| * | K041050 | Digora Optime (or Digora Ontime)Summary page 2…ognize imaging plates as they are scanned. 7. Substantial Equivalence The CS 7600 is substantially equivalent the Kodak CR 7400 (K060079) and the Soredex Digora Optime (K041050). Each listed device is a computed radiography device utilizing phosphor plates for dental diagnostic imaging. The devices are eq… | 2004 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 3 companies; a new generation was cleared every 10.3 years on median.
- 1 of the 3 ancestors has a recall of any class.
How does its category compare?
All MUH devicesMUH System, X-Ray, Extraoral Source, Digital: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · MUH
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MUH
159in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MUH
1in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MUH
1in 2025
MAUDE reports naming product code MUH, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 11 | 48 | 0 | 0 |
| 2008 | 8 | 64 | 1 | 0 |
| 2009 | 9 | 88 | 2 | 12 |
| 2010 | 9 | 174 | 0 | 9 |
| 2011 | 10 | 89 | 0 | 0 |
| 2012 | 9 | 81 | 0 | 5 |
| 2013 | 9 | 172 | 1 | 1 |
| 2014 | 8 | 168 | 1 | 5 |
| 2015 | 12 | 111 | 1 | 3 |
| 2016 | 6 | 47 | 0 | 1 |
| 2017 | 9 | 84 | 0 | 4 |
| 2018 | 3 | 29 | 0 | 10 |
| 2019 | 5 | 64 | 0 | 6 |
| 2020 | 5 | 36 | 0 | 0 |
| 2021 | 10 | 80 | 0 | 1 |
| 2022 | 7 | 57 | 0 | 0 |
| 2023 | 11 | 57 | 0 | 1 |
| 2024 | 4 | 144 | 0 | 0 |
| 2025 | 3 | 159 | 0 | 1 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The CS 7600 is indicated for use in dental digital radiography using imaging plates (phosphor storage screens) for dental intra-oral x-ray imaging.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K111649 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111649: CS 7600.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111649
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026